Events

Device Recall ADVIA Centaur Cortisol Assay 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Healthcare Diagnostics, Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    61393
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1390-2012
  • 사례 시작날짜
    2012-03-06
  • 사례 출판 날짜
    2012-04-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-06-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107987
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Fluorometric, cortisol - Product Code JFT
  • 원인
    Cortisol assay reagent kit lots do not meet onboard stability and calibration interval claims.
  • 조치
    The firm, Siemens Healthcare, sent an "Urgent Field Safety Notice" via e-mail to all affected customers on March 6, 2012 in the United States and International. The Urgent Field Safety Notice describe the product, problem, and actions to be taken. The notice instructed the customers to perform daily calibration on all Cortisol reagent kits to maintain consistently accurate quality control and patient values; to complete and return the confirmation fax-back form 'Field Correction Effectiveness Check' via fax to the Technical Solutions Center at (302) 631-7597 and forward this notification to whomever they many have distributed this product. If you have any questions, contact Quality Engineer 5- Quality Systems and Compliance at 508-660-8540 or www.siemens.com/diagnostics.

Device

Device Recall ADVIA Centaur Cortisol Assay
  • 모델명 / 제조번호(시리얼번호)
    AD VIA Centaur¿ Cortisol reagent kit lots from the reagent lots ending with the following three digits: 254, 255, 256, 257. Kit Lot# 50 Test  70078254 70860254 72058254 73346254 74543254 75397254 76332255 77366255 78595255 79146255 80596255 81274255 82938256 83522256 84771256 86150257 250 Test  69991254 70470254 73049254 74027254 76202255 78071255 80179255 81497255 82689256 83316256 86138257 250 Test  73880254 77890255 80812255 83456256 86151257 Not Applicable . Expiry Date 23 May 2012 23 May 2012 23 May 2012 23 May 2012 23 May 2012 23 May 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 15 Feb 2013 15 Feb 2013 15 Feb 2013 09 May 2013 23 May 2012 23 May 2012 23 May 2012 23 May 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 15 Feb 2013 15 Feb 2013 09 May 2013 05 May 2012 07 Oct 2012 07 Oct 2012 15 Feb 2013 09 May
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distributed: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, AUSTRALIA, BANGLADESH, BD, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, EGYPT, GERMANY, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, JAPAN, KOREA, MALAYSIA, MEXICO, NEW ZEALAND, PAKISTAN, PHILIPPINES, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, TAIWAN, THAILAND, URUGUAY, VENEZUELA, and VIETNAM.
  • 제품 설명
    Siemens ADVIA Centaur Cortisol Assay || Cat. Nos. || 04610138 (1 0321 026)- 250 Test kit || 04610049(10309078)- 50 Test kit || 04611509 (1 0335503)- 250 REF Test kit || ADVIA Centaur Systems Cortisol: For in vitro diagnostic use in the quantitative determination of cortisol in serum or urine using the ADVIA Centaur and ADVIA Centaur XP systems.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc

Manufacturer

Siemens Healthcare Diagnostics, Inc
  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA